Computer System Validation Consultant
hace 1 semana
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Due to a constant growth, we are looking for a Computer System Validation Consultant to join our team in Barcelona or Madrid, Spain. This is a hybrid role (2 days working from home ) and requires strong Spanish language skills at a professional level. Responsibilities include, but are not limited, to the following: Support in Computer System Validation (CSV) activities: Contribute to the execution of CSV projects, ensuring alignment with GxP requirements, 21 CFR Part 11, EU Annex 11, and applicable guidelines. Preparation of validation documentation: Assist in drafting and reviewing technical documents such as validation plans, protocols (IQ/OQ/PQ), reports, and risk assessments. Execution of testing activities: Participate in protocol execution, test result documentation, and deviation management as needed. Support in risk assessments: Collaborate in collecting information, performing preliminary risk analyses, and defining mitigation actions. Cross-functional collaboration: Work closely with IT, Quality Assurance, and other business functions to ensure proper implementation of compliance requirements. Regulatory awareness: Stay informed about relevant regulations and industry best practices related to computer system validation. Client support: Provide operational and consulting support to clients during CSV activities. Requirements: Bachelor’s or Master’s degree in Scientific or Technical disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.). 1–3 years of experience in the Pharmaceutical industry or in a related validation/qualification role. Basic to intermediate understanding of GxP regulations , 21 CFR Part 11 , EU Annex 11 , and other compliance requirements. Native-level Spanish (mandatory) and good command of English (B1–B2). Familiarity with GxP-regulated computer systems , test management tools, and CSV-related tools. Strong skills in technical documentation preparation and updating. Good organizational skills , teamwork attitude, problem-solving mindset, and motivation to grow in the CSV consulting field. Location: Barcelona or Madrid, Spain Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. xsgfvud Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
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Computer System Validation Consultant
hace 5 días
Madrid, España PQE Group A tiempo completoAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .Due to a constant growth, we are looking for a Computer System Validation...
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Computer System Validation Consultant
hace 5 días
Madrid, España PQE Group A tiempo completoAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.Due to a constant growth, we are looking for a Computer System Validation Consultant...
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Computer System Validation Consultant
hace 1 semana
Madrid, España PQE Group A tiempo completoAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. Due to a constant growth, we are looking for a Computer System Validation...
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Computer System Validation Consultant
hace 5 días
Madrid, España PQE Group A tiempo completoAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to a constant growth, we are looking for a Computer System Validation...
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Computer System Validation Consultant
hace 4 días
Madrid, España PQE Group A tiempo completoAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Due to a constant growth, we are looking for a Computer System Validation...
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Computer System Validation Consultant
hace 4 semanas
Madrid, España PQE Group A tiempo completoAre you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries?PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas.Due to a constant growth, we are looking for aComputer System Validation Consultantto join...
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Csv (computer system validation)
hace 2 semanas
Madrid, España ADEAS HR - PASSION FOR PEOPLE A tiempo completoImportante Multinacional Farmacéutica, situada en Sant Cugat del Vallés precisa incorporar a su equipo: CSV (COMPUTER SYSTEM VALIDATION) La persona seleccionada se incorporará al Departamento de QA Systems-Product el cual tiene la responsabilidad de implementar y mantener los sistemas que garanticen el cumplimiento GMP (APQRs, CSV& C, revisión y...
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CSV (COMPUTER SYSTEM VALIDATION)
hace 3 semanas
Madrid, España ADEAS HR - PASSION FOR PEOPLE A tiempo completoImportante Multinacional Farmacéutica, situada en Sant Cugat del Vallés precisa incorporar a su equipo:CSV (COMPUTER SYSTEM VALIDATION)La persona seleccionada se incorporará al Departamento de QA Systems-Product el cual tiene la responsabilidad de implementar y mantener los sistemas que garanticen el cumplimiento GMP (APQRs, CSV&C, revisión y aprobación...
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Computer System Validation Technician
hace 5 días
Madrid, España Takeda Pharmaceutical A tiempo completoJOB TITLE**:Computer System Validation Technician** LOCATION**:Tres Cantos - Spain** ABOUT THE ROLE: **_ OBJECTIVES/PURPOSE _** Based at our Cell Therapy plant in Madrid, CSV Technician will be responsible to lead and manage site CSV validation activities: - Manage / Execute the CSV projects that are assigned according to the needs of Takeda Madrid Cell...
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Computerized System Validation Coordinator
hace 6 días
Madrid, España Insud Pharma A tiempo completoOverview: Ensure that GxP critical electronic systems meet regulatory standards, maintain data integrity, and contribute to the overall quality and compliance objectives of the organization. **Responsibilities**: - **Validation Strategy**: Develop and implement a validation strategy for electronic systems, ensuring compliance with industry regulations and...
